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Methylprednisolone for Knee Arthritis
Phase 4
Recruiting
Led By Ajay Premkumar, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing whether a short-term course of medication can reduce pain, nausea, and the need for opioids in patients after knee replacement surgery. The study involves patients who are having knee replacement surgery and aims to see if this medication can improve their recovery by reducing inflammation. Certain medications have been shown to improve recovery and reduce nausea in various surgical settings.
Who is the study for?
This trial is for patients aged 18 to 95 who are undergoing their first total knee replacement due to severe knee arthritis. It's not suitable for those with other conditions that might affect the surgery or recovery.
What is being tested?
The study tests if a short-term steroid medication called Medrol Dose Pak can reduce pain, nausea, and opioid use after knee replacement surgery compared to standard post-surgery care.
What are the potential side effects?
Possible side effects of Methylprednisolone include increased blood sugar levels, mood swings, increased risk of infection, high blood pressure, and stomach ulcers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Nausea score during Follow Up Period
Changes in Pain Score during Follow up period
Secondary study objectives
Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)
Changes in the postoperative range of motion following total knee arthroplasty (TKA)
Compare patient satisfaction with acute postoperative pain control
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group: Medrol DoseExperimental Treatment1 Intervention
The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.
Group II: Control Group: Standard of CareActive Control1 Intervention
Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for knee arthritis include glucocorticoids, NSAIDs, and biologics. Glucocorticoids, like the Medrol Dose Pak, reduce inflammation by blocking the inflammatory process, which helps decrease pain and swelling.
NSAIDs work by inhibiting prostaglandin synthesis, thereby reducing inflammation and pain. Biologics target specific components of the immune system to reduce inflammation.
Understanding these mechanisms is important for knee arthritis patients as it helps in selecting the most effective treatment based on the specific inflammatory pathways involved in their condition.
[Methods and statistics of multicentral double-blind "cross-over" examination of naproxen compared to indomethacin].A comparison of synovial fluid concentrations of non-steroidal anti-inflammatory drugs with their in vitro activity.[Pharmacological studies of N-(2-mercapto-2-methylpropanoyl)-L-cysteine (SA96). V. Effects of SA96 in combination with indomethacin or prednisolone on adjuvant arthritis in rats].
[Methods and statistics of multicentral double-blind "cross-over" examination of naproxen compared to indomethacin].A comparison of synovial fluid concentrations of non-steroidal anti-inflammatory drugs with their in vitro activity.[Pharmacological studies of N-(2-mercapto-2-methylpropanoyl)-L-cysteine (SA96). V. Effects of SA96 in combination with indomethacin or prednisolone on adjuvant arthritis in rats].
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,686 Previous Clinical Trials
2,599,445 Total Patients Enrolled
Ajay Premkumar, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a minor and cannot legally consent for myself.I am having a knee replacement due to arthritis.I have a condition that weakens my immune system, and taking steroids could be harmful.I am between 18 and 95 years old.I have serious injuries to other bones or organs.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group: Medrol Dose
- Group 2: Control Group: Standard of Care
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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